NCT06867484 Breast Re-irradiation After Second Ipsilateral Lumpectomy
| NCT ID | NCT06867484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Youssef Zeidan |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 114 participants in total. It began in 2025-10-27 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with ER+HER2- breast cancer * Provision of signed and dated ICF * Stated willingness to comply with all study procedures and availability for the duration of the study * Age ≥ 40 years * Oncotype \< 26 (postmenopausal) \<16 (premenopausal), Low, or Ultra-Low index. * Minimum interval of 18 months from last breast radiotherapy session. * Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records available. * Ipsilateral recurrence, unifocal \< 3 cm with negative margins, N0, Tis and invasive (pathological staging) * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Planning target volume: whole breast (PTV: WB) ratio \< 1/2 * Life expectancy \> 12 months * Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. A person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1. Has not undergone a hysterectomy or bilateral oophorectomy; or 2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months) Exclusion Criteria: * BRCA1/2 mutation or any other receptor subtypes * Individuals assigned male at birth with breast cancer * Pregnancy or breastfeeding * Skin involvement * Distant metastasis * Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial primary tumor information will be recorded as missing on the clinical forms. * Other malignancies (except skin) * Connective tissue disorder (e.g., scleroderma, lupus) * Any other condition that may put a participant at higher risk, at the discretion of the investigator.
Contact & Investigator
Youssef Zeidan, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Lynn Cancer Institute at Baptist Health, Inc.
Frequently Asked Questions
Who can join the NCT06867484 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06867484 currently recruiting?
Yes, NCT06867484 is actively recruiting participants. Contact the research team at youssef.zeidan@baptisthealth.net for enrollment information.
Where is the NCT06867484 trial being conducted?
This trial is being conducted at Boca Raton, United States, Miami, United States.
Who is sponsoring the NCT06867484 clinical trial?
NCT06867484 is sponsored by Youssef Zeidan. The principal investigator is Youssef Zeidan, M.D., Ph.D. at Lynn Cancer Institute at Baptist Health, Inc.. The trial plans to enroll 114 participants.
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